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Santa Barbara Press: Silicone breast implant debate back in spotlight
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Ilena Rose
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PostPosted: Sat Jun 11, 2005 2:53 pm    Post subject: Santa Barbara Press: Silicone breast implant debate back in spotlight Reply with quote

Silicone breast implant debate back in spotlight, By: Nelson, Frank,
Santa Barbara News-Press (CA), Jun 01, 2005
Database: Newspaper Source


Silicone breast implant debate back in spotlight



~~~~~~~~

Frank Nelson Jun. 1--The debate over silicone gel-filled breast
implants is a highly charged emotional issue that doesn't seem to have
cooled in the 13 years since wide-ranging health concerns swept the
products off the U.S. market.

Indeed, as two Santa Barbara implant makers, Mentor and Inamed, try to
persuade the Food and Drug Administration to relax the 1992 ban,
supporters and objectors remain as polarized as ever, arming
themselves with weapons remaining from past battles.

These deep differences bubbled to the surface when The New York Times
recently reported allegations from two former Mentor employees that
the company had sold defective implants but hid that from customers
and federal regulators.

These allegations of a cover-up and false reporting were dated -- they
surfaced through a 2003 Missouri civil court case and were made by
people who had not worked at Mentor since at least 1998.

However, that has not stopped opponents of silicone implants from
seizing on this as yet more evidence that Mentor cannot be trusted and
that the research data it recently laid before an FDA advisory panel
is highly suspect.

That attack, in turn, has triggered a withering response from Mentor,
which branded those making the allegations as "disgruntled former
employees" and questioned the motives of others who have sought to
capitalize on what the company sees as false and discredited
information.

The company also points the finger of suspicion at the timing of this
latest story, which comes as the FDA is on the verge of delivering a
ruling on whether to allow resumption of silicone implant sales.

While silicone has been cleared of causing such major health problems
as cancer and lupus, questions persist over how likely the implants
are to rupture or leak -- especially over time -- and what effect
escaping silicone may have on a woman's health.

Silicone is widely used overseas and is said to look and feel more
natural than saline implants, which account for most of the roughly
250,000 breast augmentations done in the U.S. each year.

The FDA is currently reviewing last month's 7-2 advisory panel vote in
favor of Mentor's application and a 5-4 vote against a similar
proposal from Inamed, which apparently narrowly failed to satisfy
lingering concerns about how often its implants break and leak.

"All of these allegations are old news," said a statement from Josh
Levine, Mentor's president and chief executive. He said the two
depositions were taken as part of a lawsuit that, "after a thorough
review by the court," was dismissed on summary judgment.

"FDA conducted an investigation (from 1998 to 2002) that we believe
included these allegations, and closed the file with no action taken,"
he added.

"Further, FDA conducts regular audits of our facilities, the most
recent of which was in February and included a review of our clinical
studies and the complaint handling process. FDA reported no issues or
concerns.

"The fact that this old case continues to reappear is strong evidence
that the groups opposed to the approval of these products will stop at
nothing to mislead or distract thoughtful people away from the science
that supports approval of these products," said Mr. Levine.

Chris Fawzy, Mentor's general counsel, says he believes it was the
intention of these former employees to try to damage the company's
credibility for their own reasons.

However, he said two independent arms of government -- first the
court, then the FDA -- have examined and dismissed the allegations.
It's therefore reasonable, he said, to conclude there is no truth or
foundation to the claims.

Peter Nicholson, vice president of corporate development, said Mentor
itself also investigated the allegations, as it does in any such
cases.

He criticized the emergence of these claims "out of the blue" two
years after they were included in a Greene County, Mo., lawsuit and
called it a "quantum leap" to try linking this to the company's
current FDA application.

He said the FDA had "thoroughly investigated" the allegations when
they were first made and closed the case saying there were no grounds
for action; then, and during the recent advisory panel hearing, there
was no question regarding the credibility of Mentor's data, said Mr.
Nicholson.

Kathleen Quinn, director of media relations at the FDA, confirmed that
the agency was aware of the allegations at the time of the recent
advisory panel hearings. "Mentor's application is still before the
agency, therefore we cannot discuss any further," she added.

Drawing a bead on those who have used these allegations to renew
debate over the accuracy of Mentor's research findings, Mr. Nicholson
said special interest groups are not using real facts and data. "We
hold ourselves to a higher standard," he said.

However, those in the opposition camp refuse to back down and believe
they can counter each of Mentor's arguments.

Kim Hoffman was the woman who filed the lawsuit, subpoenaed the Mentor
employees, gave copies of their depositions to The Times ... and
claims her life has been ruined by faulty implants she received in
1995.

She says the experience ruined her health, cost her thousands of
dollars in medical expenses and, as neurological problems set in,
doomed her business -- the ownership and administration of two
preschools.

"I went through hell and my family went through hell," says the
44-year-old Springfield, Mo., resident.

She says what started her on the road to court and got her involved in
the whole silicone implant debate was the refusal of her doctor and
Mentor to include her case in ongoing studies of the effects implants
were having on women.

She says the court case failed because of mistakes and omissions by
her attorney and had nothing to do with the validity of evidence
supplied by former Mentor employees who alleged implant rupture rates
were under-reported and covered up.

Similarly, Ms. Hoffman claims that while the FDA kept open a criminal
investigation into the allegations for four years, officials failed to
follow up on information that was brought forward by many employees.

For proof of this, she cites the January 2000 resignation letter of
James Austin Templer, who between 1994 and 1999 was the FDA compliance
officer assigned to handle Mentor.

Mr. Templer quit the agency after complaining that the FDA's Office of
Criminal Investigations (OCI) "will not conduct a thorough criminal
investigation of Mentor Corporation after years of allegations."

"Unfortunately, OCI does not have the interest or ability and will not
expend the resources to thoroughly investigate Mentor and I am very
concerned that it appears FDA is trying to cover up the facts and
discredit those who wish to see justice served," his resignation
letter read.

"My concerns are based on the evidence at hand and numerous credible
informants that allege criminal conduct regarding Mentor's manufacture
and study of saline and silicone gel-filled breast implants and tissue
expanders."

The Times at first mistakenly said it was given the court depositions
by the National Research Center for Women and Families. While this was
later corrected, the nonprofit center's president, Diana Zuckerman,
took the opportunity to press her organization's opposition to the
reintroduction of silicone implants.

At the very least, she said, this latest story raises questions about
the credibility of Mentor's data, especially when the company is now
reporting much lower failure rates than its rival manufacturer,
Inamed.

Are those differences because the product is so much better, she
wondered?

Or is Mentor falsifying data or are there some irregularities in the
research methodology?

Ms. Zuckerman was a post-doctoral fellow in epidemiology and public
health at Yale Medical School and later worked on the faculty at
Vassar College and Yale. She left Yale to direct a research project at
Harvard.

For 10 years she worked in Congress for the House subcommittee that
has jurisdiction over the U.S. Department of Health and Human
Services, including the FDA. She was responsible for more than a dozen
congressional investigations and hearings on a wide range of health
issues, including the first congressional hearings on breast implants.

She is critical of the way in which Mentor has compiled research data,
accusing the company of setting parameters that help skew the results
in its favor. She believes ongoing concerns point to a "pattern of
selectivity" and a way of analyzing data that makes Mentor look good.

"I know what clinical studies are supposed to look like," says Ms.
Zuckerman, who has been involved in the implant issue since before the
ban on silicone. "If my students had turned in research like this I
would have failed them, and failed them badly."

However, Mentor believes in the integrity of its research and says the
green light from the advisory panel in April supports this confidence.
"The panel deserves a lot of credit for thoroughly examining the
scientific data before reaching the same conclusion we have reached --
that Mentor's silicone gel-filled breast implants are a safe and
effective option for women," said Mr. Levine at that time.

Thom Gunderson, a health care analyst with Piper Jaffray in
Minneapolis, doubts the latest media story will have any effect on
Mentor or the FDA's deliberations.

He says investors tend to react quickly to bad news and since Mentor's
stock "continued to hold up nicely" despite The Times story he takes
that as a sign that most people consider this as nothing new.

Mr. Gunderson thinks the FDA will probably take a look at the matter
but he doubts there would even have been an advisory panel meeting
last month if the allegations had not already been thoroughly
investigated.

~~~~~~~~~~

www.BreastImplantAwareness.org
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